VIACORAM TABLET 14 MG10 MG

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Amlodipine besilate 13.87 mg corresponding to amlodipine; Perindopril 9.512 mg corresponding to perindopril arginine

Tilgængelig fra:

SERVIER (S) PTE LTD

ATC-kode:

C09BB04

Lægemiddelform:

TABLET

Sammensætning:

Amlodipine besilate 13.87 mg corresponding to amlodipine 10 mg; Perindopril 9.512 mg corresponding to perindopril arginine 14 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Servier (Ireland) Industries Ltd.

Autorisation status:

ACTIVE

Autorisation dato:

2018-10-01

Produktets egenskaber

1
SUMMARY PRODUCT INFORMATION
VIACORAM
®
START 3.5 mg/2.5 mg tablets
VIACORAM
®
7 mg/5 mg tablets
VIACORAM
®
14 mg/10 mg tablets
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
tablets
3.5 mg/2.5 mg,
7 mg/5 mg and
14 mg/10 mg
Lactose monohydrate,
Cellulose, microcrystalline (E460),
Silica, colloidal anhydrous (E551),
Magnesium stearate (E470B).
_For a complete listing see _
DOSAGE FORMS,
COMPOSITION AND PACKAGING
_section. _
INDICATIONS AND CLINICAL USE
VIACORAM
®
(perindopril arginine and amlodipine) is indicated for the treatment
of mild to
moderate essential hypertension in patients for whom combination
therapy is appropriate.
VIACORAM
®
START 3.5 mg/2.5 mg is indicated for initial therapy in patients with
mild to
moderate essential hypertension.
VIACORAM
®
is not indicated for switching therapy from the individual drugs
currently on the
market
(perindopril
as
erbumine
or
arginine
salt,
amlodipine)
(see
DOSAGE
AND
ADMINISTRATION section).
GERIATRICS (> 65 YEARS OF AGE):
VIACORAM
®
is not indicated for the initiation of treatment in elderly patients.
There is no
sufficient clinical experience to justify the use in the elderly (> 65
years).
PEDIATRICS (< 18 YEARS OF AGE):
VIACORAM
®
is not indicated in pediatric patients <18 years of age. The efficacy
and safety have
not been studied in this population.
CONTRAINDICATIONS
VIACORAM
®
(perindopril arginine and amlodipine) is contraindicated in:
-
Patients who are hypersensitive to the active ingredients of this
drug, to any ingredient in the
formulation or component of the container, to any other angiotensin
converting enzyme inhibitor
(ACE-inhibitor), or to any other dihydropyridine derivatives.
For a complete listing, see
DOSAGE FORMS, COMPOSITION and PACKAGING section of the product
monograph.
2
-
Patients with renal impairment (creatinine clearance < 60 ml/min) (see
WARNINGS and
PRECAUTIONS, Renal).
-
Patients with a history of hereditary/idiopathic angioedema, or
angioedema related to previous
treatment with an ACE-in